MAUDE Adverse Event Report: CORDIS CORPORATION CATH F5.2+ JL3.5 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 533551

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2021

Event Type  malfunction  

Manufacturer Narrative

The product history review is expected but has not been completed.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, a 5f judkins left 3.5 100cm super torque plus diagnostic catheter leaked externally into the patient.The procedure was completed using another unknown catheter.There was no reported patient injury.The event did not cause a clinically relevant increase in the duration of the procedure.The event did not cause a condition that requires hospitalization or significant prolongation of existing hospitalization.The incident extended the procedure no more than 15 minutes.The procedure was a coronary angiography.The intended vessel was the middle anterior interventricular artery.This was not for a cto.The vessel diameter was 3mm with normal coronary flow but had a very tight stenosis.The percentage of stenosis was 70-90%.There were no anomalies noted when removed from the package nor during prep.The device was not inserted through a stopcock instead of a hemostatic valve.There was no resistance met while advancing the device.Excessive torqueing was not required.There was no resistance met while advancing the device over the guidewire.The device did not kink at any part.Other procedural details were requested but are unknown, unavailable, or not applicable.The device will be returned for evaluation.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18047815 presented no issues during the manufacturing process that can be related to the reported event.This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Complaint conclusion: as reported, a 5f judkins left 3.5 100cm super torque plus diagnostic catheter leaked externally into the patient.The procedure was completed using another unknown catheter.There was no reported patient injury.The event did not cause a clinically relevant increase in the duration of the procedure.The event did not cause a condition that requires hospitalization or significant prolongation of existing hospitalization.The incident extended the procedure no more than 15 minutes.The procedure was a coronary angiography.The intended vessel was the middle anterior interventricular artery.This was not for a cto.The vessel diameter was 3mm with normal coronary flow but had a very tight stenosis.The percentage of stenosis was 70-90%.There were no anomalies noted when removed from the package nor during prep.The device was not inserted through a stopcock instead of a hemostatic valve.There was no resistance met while advancing the device.Excessive torqueing was not required.There was no resistance met while advancing the device over the guidewire.The device did not kink at any part.Other procedural details were requested but are unknown, unavailable, or not applicable.The device was returned for analysis.One non-sterile cath f5.2+ jl3.5 100cm unit was received coiled for analysis inside a plastic bag.The device was unpacked to proceed with the product evaluation.During visual inspection, a puncture/hole was observed located approximately at 6.6 cm from distal tip.No other anomalies were observed by the naked eye.Per functional analysis, a flushing test was performed, and a leak was noted coming out of the puncture/hole found during visual review.Sem analysis was performed, and results showed that the inner surface of the catheter unit presented material elongations along the puncture/hole.The outer surface presented evidence of scratch marks near the puncture/hole.This type of damage is commonly caused during the interaction of the catheter material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed material elongations, the cup and cone shape-like observed on the braid wires and scratch marks on the unit¿s outer and inner surfaces could have led to the punctured condition found on the received unit.Based on the available evidence, it seems the catheter material was punctured with a sharp object from the outside of the unit.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 18047815 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The event reported by the customer as ¿catheter (body/shaft) leakage - in-patient¿ and subsequent findings of ¿catheter (body/shaft) puncture/cut¿ were confirmed since a puncture/hole was found on the body/shaft of the returned device.However, the exact cause of the damages could not be determined.During functional analysis and once the device was flushed, a leakage of fluid was noted coming from the hole.The outer surface of the shaft presented evidence of scratch marks adjacent to the puncture noted.The body/shaft material near the puncture, appears to have been torn either due to the interaction of the device with calcified spicules located on the lesion or with a sharp object from the outside of the shaft.Therefore, based on the information available for review, it is likely procedural factors and vessel characteristics of a ¿very tight stenosis¿ likely contributed to the events reported and damage to the catheter shaft ensued upon delivery of the device to the lesion.According to the precautions in the instructions for use, ¿the performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.For all catheters: keep the catheter filled with either flushing solution or contrast medium while the catheter is in the vascular system and consider the use of systemic heparinization.Exercise care when removing guidewires from multiple-curve catheters.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.

• Brand Name: CATH F5.2+ JL3.5 100CM
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 13190406
• MDR Text Key: 283491569
• Report Number: 9616099-2022-05266
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032012669
• UDI-Public: 10705032012669
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K862244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 533551
• Device Catalogue Number: 533551
• Device Lot Number: 18047815
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN CATHETER.
• Patient Age: 82 YR
• Patient Sex: Male